IMPELLA, Complications and Tolerance

Condition(s) studied

Investigational drug(s) / intervention(s)

Impella (5, 5.5 or CP): Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support

Study summary

Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.

Eligibility

Primary outcome measure(s)

• Hemocompatibility related adverse events (HRAEs) — From start of hospitalization until hospital discharge, assessed up to 3 month
  Incidence of HRAEs with Impella (CP and/or 5 - 5.5) : Bleeding events (BARC \>3b) and Thrombosis events ( ischemic stroke + pump thrombosis)

Trial sites (1)

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